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Efficacy and Safety of Pancrelipase Delayed Release Capsules in Young Children with CF

Study Type:

Interventional

Intervention Category:

Nutritional-GI Therapies

Study Sponsor:

AbbVie

Study Phase:

3

Recruitment Status:

Trial Completed

Study Drug(s):

Creon

Number of Participants Being Recruited:

18

Single / Multi-Center:

Multi-Center

STUDY BACKGROUND INFORMATION:

Pancreatic enzyme replacement therapy is important for normal growth and development in children with CF who have pancreatic insufficiency. The use and safety of current enzyme replacement therapy has been shown in other clinical trials in CF patients with pancreatic insufficiency. This study will look at the use and safety of a new formulation of an enzyme replacement therapy and its effect on fat absorption in CF patients with pancreatic insufficiency.

ELIGIBILITY

Age:

1 Months - 6 Years

FEV1:

Not Applicable

P. aeruginosa status:

Not applicable

B. cepacia status:

Not applicable

Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.

The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.